A Phase 1b/2, First-in-Human, Dose Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- EXP: Safety and Tolerability
研究概览
简要总结
First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. In addition to safety assessments, the pharmacokinetics of the drug were assessed along with ADC activity.
详细描述
This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) was administered as an intravenous infusion once every four weeks. Enrollment into the EXP segment consisted of 2 parallel cohorts of patients to confirm the dose that was identified in DES and estimate the objective response rate in each patient population. All adverse events were graded according to the National Cancer Institute (NCI) Common Terminology Criteria version (CTCAE v5.0). Throughout the study, pharmacokinetics were measured using proprietary assays developed by Mersana. Anti-cancer activity were measured via RECIST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Expansion - Ovarian Cancer
Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose.
This cohort is closed to enrollment.
干预措施: upifitamab rilsodotin (Drug)
Dose Expansion - NSCLC adenocarcinoma
Once the maximum tolerated dose or recommended Phase 2 dose is achieved in dose escalation, new groups of patients will receive XMT-1536 (upifitamab rilsodotin) at this fixed-dose.
This cohort is closed to enrollment.
干预措施: upifitamab rilsodotin (Drug)
结局指标
主要结局
EXP: Safety and Tolerability
时间窗: First dose up until 30 days after study termination
Evaluate incidence and severity of adverse events
次要结局
未报告次要终点